FDA Notifies Pharmaceutical Companies to Confirm or Repeat Analytic
Studies Used in the Approval of a Number of Drug Products

ROCKVILLE, Md., Jan. 10, 2007-As a precaution, the Food
and Drug Administration (FDA) is notifying certain pharmaceutical
companies to recommend that they reevaluate pharmacokinetic studies
that were conducted for them by MDS Pharma Services (MDS Pharma)
from 2000 through 2004. MDS Pharma is a contract company that
performs these pharmacokinetic testing services for a number of
pharmaceutical companies. A pharmacokinetic study is used to
measure the level of drug in a patient’s blood. The results
of the study can be part of the basis for the approval of a drug by
the Agency.

FDA is taking this action as a result of FDA inspections of two
MDS Pharma Canadian facilities that raised questions about the
validity and accuracy of test results from studies conducted by MDS
Pharma from 2000 through 2004. FDA has worked with MDS Pharma to
address these issues concerning its test results and is now
following up directly with all pharmaceutical companies with
marketed drugs or pending drug applications that may be affected by
these testing issues. FDA has identified all of the approved
generic drugs and generic drugs pending approval that are affected
by these MDS Pharma studies and is notifying these companies of
FDA's recommendation for reevaluation of these studies. For
brand-name drugs, FDA is notifying all companies that submitted
applications during the affected time period to identify any
studies conducted on their behalf by MDS Pharma.

FDA will be working with the affected companies to ensure, where
necessary, that they validate their pharmacokinetic data through
audits, new analyses or repeating their tests within a reasonable
period of time.

FDA is taking this action as a precautionary measure to ensure
that data submitted to the Agency and used in making approval
decisions is of the highest quality. FDA’s routine adverse
event surveillance monitoring program has not detected any signals
or any evidence that any of the drugs involved pose a safety risk
or that there has been any impact on efficacy. FDA does not have
any evidence that there are problems with the quality, purity, or
potency of the affected drug products